Status:
COMPLETED
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Oncologic Diseases
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborating Sponsors:
Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies
Istituti Tumori Giovanni Paolo II
Conditions:
Non Small Cell Lung Cancer
Metastatic Melanoma
Eligibility:
All Genders
18-75 years
Brief Summary
This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with non-small-cell lung cancer (NSCLC) and metastatic melanoma. Microbiota is...
Detailed Description
The primary aim of this multicentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and blood samples) subjects suffering from selected on...
Eligibility Criteria
Inclusion
- PATIENTS WITH NSLSC
- NSLSC diagnosis
- aged between 18 and 75 years
- omnivorous diet
- having suspended antibiotic therapy for at least 15 days
- cessation of treatment with cortisone for at least 15 days
- signature of the informed consent
- PATIENTS WITH METASTATIC MELANOMA
- metastatic melanoma diagnosis
- aged between 18 and 75 years
- omnivorous diet
- having suspended antibiotic therapy for at least 15 days
- cessation of treatment with cortisone for at least 15 days
- signature of the informed consent
Exclusion
- PATIENTS WITH NSLSC/METASTATIC MELANOMA
- Exclusion criteria:
- Current treatment with antibiotics or immunosuppressive drugs Previous chemotherapy treatmment Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
- Chronic liver disease
- History of Clostridium difficile infections
- Recent (\<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
- Chronic therapy with proton pump inhibitors
- Recent (\<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
- Previous history of organ / tissue transplantation
- Recent onset of diarrhea
- Chronic diarrhea
- Chronic constipation
- Previous gastrointestinal surgery (eg gastric bypass)
- Recurring urinary tract infections (3 cases per year)
- Previous major acute cardiovascular diseases (myocardial infarction, stroke)
- Type 2 diabetes mellitus
- Hypertension
- eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Psychiatric conditions that reduce protocol compliance.
Key Trial Info
Start Date :
February 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04698161
Start Date
February 25 2021
End Date
July 11 2022
Last Update
August 4 2022
Active Locations (1)
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1
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy